Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-01-29 @ 11:25 AM
Study NCT ID:
NCT03865992
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-07
First Post:
2019-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Curcumin in Reducing Joint Pain in Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003474', 'term': 'Curcumin'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-09-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2019-01-09', 'studyFirstSubmitQcDate': '2019-03-05', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Joint symptoms occurrence', 'timeFrame': 'Up to 3 months', 'description': 'The study will use logistic regression models to compare the occurrence of moderate to severe joint symptoms during the 3 month period between the two study groups, with potential covariates including geriatric assessment (GA), age, body mass index, baseline pain scores (0 month), prior chemotherapy e.g. taxanes, time to menopause/ovarian suppression. Summary statistics will be generated using the data obtained from the T0 and T3 study visits where grip strength dynamometry completed. Temporal as well as other relevant correlations between the data and the validated assessment scores will be determined.'}, {'measure': 'Blood based biomarker analysis', 'timeFrame': 'Up to 3 months', 'description': 'The study will explore the relationship between specific inflammatory blood markers, grip strength, and the joint symptoms evaluated by the patient reported outcome measures. The relationship between plasma curcumin and these measures will also be evaluated. Scatter plots and correlation coefficients (either Pearson or Spearman) will be used to summarize their pair wise relation. The differences between the treatment and placebo in terms of these measures will also be reported using numerical summaries and graphic plots.'}, {'measure': 'Adherence rates', 'timeFrame': 'Up to 3 months', 'description': 'Adherence rates will be examined using pill counts each month and patient recorded daily logs. Plasma curcumin will be compared to daily logs and pill count data as another potential measure of adherence.'}], 'primaryOutcomes': [{'measure': 'Changes in aromatase inhibitor-induced symptoms and overall wellbeing in postmenopausal women on aromatase inhibitor therapy', 'timeFrame': 'Up to 3 months', 'description': 'The study will assess the feasibility of using the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) to detect changes in aromatase inhibitor (AI)-induced symptoms and well-being in postmenopausal women with breast cancer randomized to 3 months of nanoemulsion curcumin (NEC) versus (vs) placebo capsules.'}, {'measure': 'Change in Brief Pain Inventory (BPI) pain score', 'timeFrame': 'Baseline up to 3 months', 'description': 'The scores obtained from the Disabilities of the Arm, Shoulder and Hand (DASH) and BPI, and FACT-ES assessments will be plotted over time for each arm. The agreement between these instruments will be evaluated using Altman and Bland plot after proper data transformation.'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 30 days post study-drug assessment', 'description': 'Adverse events will be characterized using the descriptions and grading scales found in the most recent version of the Common Terminology Criteria for Adverse Events version 5.0.'}, {'measure': 'Change in FACT-ES score', 'timeFrame': 'Baseline up to 3 months', 'description': 'The scores obtained from the BPI, DASH, and FACT-ES assessments will be plotted over time for each arm. The agreement between these instruments will be evaluated using Altman and Bland plot after proper data transformation'}, {'measure': 'Change in DASH score', 'timeFrame': 'Baseline up to 3 months', 'description': 'The scores obtained from the BPI, DASH, and FACT-ES assessments will be plotted over time for each arm. The agreement between these instruments will be evaluated using Altman and Bland plot after proper data transformation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'curcumin', 'aromatase inhibitor', 'joint pain', 'arthropathy'], 'conditions': ['Breast Cancer', 'Joint Pain']}, 'referencesModule': {'references': [{'pmid': '38280052', 'type': 'DERIVED', 'citation': 'Lustberg M, Fan-Havard P, Wong FL, Hill K, Phelps MA, Herrera KW, Tsai NC, Synold T, Feng Y, Kalu C, Sedrak MS, Yee LD. Randomized placebo-controlled, double-blind clinical trial of nanoemulsion curcumin in women with aromatase inhibitor-induced arthropathy: an Alliance/NCORP pilot trial. Breast Cancer Res Treat. 2024 May;205(1):61-73. doi: 10.1007/s10549-023-07223-4. Epub 2024 Jan 27.'}]}, 'descriptionModule': {'briefSummary': 'This phase I trial studies how well curcumin works in reducing joint pain in patients who are breast cancer survivors and have joint disease caused by treatment with aromatase inhibitors. Curcumin is an ingredient of turmeric, a plant in the ginger family, which is commonly used in curries and South Asian and Middle Eastern cooking, and may decrease joint pain in patients with arthritis from other conditions (such as osteoarthritis and rheumatoid arthritis).', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To evaluate the feasibility of using Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) scores to detect changes in AI-induced symptoms and well-being in postmenopausal women with breast cancer at 3 months of nanoemulsion curcumin (NEC) vs placebo\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate Disabilities of the Arm, Shoulder and Hand (DASH), Brief Pain Inventory, and Geriatric Assessment as secondary tools for monitoring AI-induced symptoms and well-being II. To evaluate adherence to a regimen of NEC vs placebo by postmenopausal women experiencing joint arthropathy induced by aromatase inhibitor therapy III. To obtain preliminary data regarding function in women with AI induced arthropathy (IA) by monitoring grip strength at 0 and 3 months of NEC versus placebo IV. To conduct exploratory analyses of blood based biomarkers in postmenopausal women with AI-induced arthropathy taking NEC vs placebo.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients receive nanoemulsion curcumin orally (PO) twice daily (BID) for up to 3 months in the absence of disease progression or unacceptable toxicity.\n\nARM II: Patients receive placebo PO BID for up to 3 months in the absence of disease progression or unacceptable toxicity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with histologically confirmed primary invasive adenocarcinoma of the breast, stages I-IIIA\n* Estrogen-receptor positive (ER+) and/or progesterone-receptor positive (PR+) breast cancer\n* Completion of definitive surgery with mastectomy or breast conserving therapy\n* Postmenopausal (no menses \\>= 12 months) or on ovarian suppression in order to take AIs\n* Currently taking an Food and Drug Administration (FDA) approved third-generation aromatase inhibitor (e.g., anastrozole \\[Arimidex\\], letrozole \\[Femara\\], or exemestane \\[Aromasin\\]) for \\>= 90 days prior to registration with plans to continue for \\>= 90 days after registration\n* Clinical symptoms of joint pain for at least 3 months prior to study entry that started or increased with AI therapy with Brief Pain Inventory (BPI) Worst Pain score \\>= 4 (verbal response to BPI question 3 regarding the worst pain in the past 24 hours as 0 "no pain" to 10 "pain as bad as you can imagine")\n\nExclusion Criteria:\n\n* Prior malignancy =\\< 5 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ of the breast or adequately treated stage I or II cancer from which the patient is currently in complete remission\n* History of a bleeding tendency or current use of coumadin or other anticoagulants\n* Current or previous history of anemia\n* Current autoimmune, liver, hematopoietic, cardiac, or renal disease\n* Current viral, bacterial, atypical or fungal infections of any organ system\n* Concurrent use of immunosuppressant medications\n* Concurrent use of medications known to inhibit or induce hepatic enzyme CYP 3A4 (e.g. ketoconazole, macrolide antibiotics, barbiturates)\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements\n* Bone fracture or surgery of the affected joints, within 180 days of study entry\n* Medical therapy, alternative therapy, or physical therapy for joint pain/stiffness =\\< 30 days of study entry\n* Intra-articular steroids =\\< 90 days of study entry or oral/intramuscular corticosteroids \\< 30 days of entry\n* Use of analgesics (e.g., opiates, tramadol with the exception of nonsteroidal anti-inflammatory drugs \\[NSAIDs\\] and acetaminophen) within 14 days prior to registration, or at any time during the 3-month study period\n* Chronic use of any herbal or dietary supplement containing curcumin or curcuminoids =\\< 3 months of study entry or any other supplements that might interact with NEC (e.g. St. John\'s Wort)\n* Known sensitivity or allergy to turmeric spices or curry'}, 'identificationModule': {'nctId': 'NCT03865992', 'briefTitle': 'Curcumin in Reducing Joint Pain in Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Disease', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Curcumin for Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Arthropathy - A Randomized, Double-Blinded, Controlled Pilot Study', 'orgStudyIdInfo': {'id': '18432'}, 'secondaryIdInfos': [{'id': 'NCI-2018-03787', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '18432', 'type': 'OTHER', 'domain': 'City of Hope Medical Center'}, {'id': 'UG1CA189823', 'link': 'https://reporter.nih.gov/quickSearch/UG1CA189823', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (nanoemulsion curcumin)', 'description': 'Patients receives nanoemulsion curcumin orally (PO) twice daily (BID) for up to 3 months in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Dietary Supplement: Curcumin', 'Other: Nanoemulsion', 'Other: Quality-of-Life Assessment', 'Behavioral: Questionnaire']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II (placebo)', 'description': 'Patients receive placebo PO BID for up to 3 months in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Curcumin', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['C.I. 75300', 'C.I. Natural Yellow 3', 'Diferuloylmethane', 'Turmeric Yellow', '(E,E)-1,7-Bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione, 32982, 458-37-7'], 'description': 'Given capsules for oral administration', 'armGroupLabels': ['Arm I (nanoemulsion curcumin)']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['placebo therapy', 'PLCB', 'sham therapy'], 'description': 'Given capsules for oral administration', 'armGroupLabels': ['Arm II (placebo)']}, {'name': 'Nanoemulsion', 'type': 'OTHER', 'description': 'Given nanoemulsion curcumin PO', 'armGroupLabels': ['Arm I (nanoemulsion curcumin)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment,'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (nanoemulsion curcumin)']}, {'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'otherNames': ['Questionnaires'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (nanoemulsion curcumin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '91730', 'city': 'Rancho Cucamonga', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Rancho Cucamonga', 'geoPoint': {'lat': 34.1064, 'lon': -117.59311}}, {'zip': '91030', 'city': 'South Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope South Pasadena', 'geoPoint': {'lat': 34.11612, 'lon': -118.15035}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Lisa D Yee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}